Advanced Squamous Cell Carcinoma of the Head and Neck MedDRA version: 9.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease-Related: • Histologically or cytologically confirmed SCC of oral cavity, oropharynx, hypopharynx, or larynx • Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition • ECOG performance status of 0 or 1 (refer to Appendix H) • Bidimensionally measurable disease = 10 mm in at least 1 dimension Demographic: • Man or woman = 18 years of age Laboratory: Hematological function, as follows (= 10 days prior to randomization): • Absolute neutrophil count (ANC) = 1.5 x 109/L • Platelet count = 100 x 109/L • Hemoglobin = 9 g/dL Renal function, as follows (=10 days prior to randomization): • Creatinine clearance = 50 mL/min as calculated from 24 hour urine collection (required for subjects with serum Cr > ULN) or calculated from the Cockcroft - Gault formula as follows: • Male creatinine clearance = (140 - age) x (weight in kg) / (serum Cr x 72) • Female creatinine clearance = (140 - age) x (weight in kg) x 0.85/(serum Cr x 72) Hepatic function, as follows (=10 days prior to randomization): • Aspartate aminotransferase (AST) = 2 x ULN • Alanine aminotransferase (ALT) = 2 x ULN • Total bilirubin = 2 x ULN Metabolic function, as follows (=10 days prior to randomization): • Serum magnesium = LLN • Negative pregnancy test = 72 hours prior to randomization (females of child bearing potential) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease Related: • Primary tumor of the nasopharynx, sinuses, salivary gland, or skin • Subjects requiring prophylactic tracheostomy • Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for = 3 years Medications or Radiotherapy: • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule tyrosine kinase inhibitors of EGFr (eg, gefitinib, erlotinib, lapatinib) • Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) • Prior radiotherapy in the planned field • Prior systemic chemotherapy for the study cancer • Major surgery = 28 days before randomization or minor surgery = 14 days before randomization with the exception that feeding tube placement, dental extractions, central venous catheter placement, biopsies (endoscopic or otherwise), and nodal sampling are allowed at any time prior to randomization • Known allergy or hypersensitivity to any component of the study drugs General: • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year prior to randomization • Chronic obstructive pulmonary disease resulting in hospitalization due to pneumonia or respiratory decompensation = 6 months prior to screening • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan • Active infection requiring systemic treatment or any uncontrolled infection = 14 days prior to randomization • Any uncontrolled condition, which, in the opinion of the investigator, would interfere in the safe and timely delivery of study treatment • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, chronic active hepatitis B infection or any co-morbid disease that would increase the risk of toxicity • Pregnant or breast-feeding women • Men not willing to use adequate contraception precautions for the duration of the study and for 1 month following the last administration of study treatment • Women of childbearing potential not using adequate contraception precautions for the duration of the study and for 6 months following the last administration of study treatment • Subject unwilling or unable to comply with study requirements • Participation in other investigational device or drug studies within 30 days before randomization • Previously randomized into this study • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study will be to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN).;Secondary Objective: Secondary: To estimate the difference between 2 treatment regimens (CRT vs PRT) on other measures of clinical benefit, including LRC, overall response rate (ORR), progression-free survival (PFS), overall survival (OS); and safety. Tertiary: To estimate the difference in health-related quality of life (HRQoL) and performance status in subjects receiving PRT or CRT. Exploratory: To investigate potential biomarker development based on assessment of blood and tumor and the proposed mechanism of actions of study drugs. In addition, to investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN and subject response to study drugs (separate informed consent required). ;Primary end point(s): Local-regional control (LRC) rates at 2 years: Defined as the Kaplan-Meier estimate of the proportion of subjects with LRC at 2 years. See below for the definition of duration of LRC. | — |
Countries
Belgium, Czech Republic, Spain, United Kingdom
Outcome results
None listed